BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 6849258 · Received September 7, 2017

    Report

    Report Number
    3005802238-2017-00003
    Event Type
    Death
    Date Received
    September 7, 2017
    Date of Event
    August 8, 2017
    Report Date
    September 6, 2017
    Manufacturer
    SENTREHEART, INC.
    Product Code
    GAT
    PMA / PMN Number
    K153096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION REVEALED THE LAA WAS A 42 MM "SUPERIOR C" SHAPE WITH AN ILL DEFINED DISTAL TIP WHICH EXTENDED BACK ONTO ITSELF BACK TO THE OSTIUM OF THE LAA. THIS CHALLENGING ANATOMY MAY HAVE CONTRIBUTED TO THE EVENT IN THAT IT MAY HAVE CONTRIBUTED TO INCORRECT POSITIONING OF THE SNARE LOOP AND SUBSEQUENT SUTURE PLACEMENT.

    Description of Event or Problem · 1

    THE LARIAT WAS BEING USED TO LIGATE THE LEFT ATRIAL APPENDAGE. FOLLOWING SUTURE TIGHTENING THE PATIENT BECAME UNSTABLE. THE CASE WAS UNREMARKABLE UP TO THAT POINT. THE DOCTOR THEN OBSERVED AN EFFUSION HAD DEVELOPED AND MADE THE DECISION TO SEND THE PATIENT TO SURGERY. REGRETTABLY, THE PATIENT EXPIRED DURING SURGERY. THE SURGEON REPORTED FINDING A LACERATION NEAR THE BASE OF THE LAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629292 LARIAT SUTURE DELIVERY DEVICE SUTURE DELIVERY DEVICE GAT SENTREHEART, INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R